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Surveillance of Pharmaceutical Risk-Mitigation Behavior: Applying and Comparing Statistical Process Control Methods
Harris Butler1,2, John D Rice1,3, Nichole E Carlson1
1Department of Biostatistics and Informatics University of Colorado Anschutz Medical Campus Aurora Colorado USA.
Learning Health Systems
|June 10, 2026
Summary
A new statistical process control (SPC) method effectively monitors prescribing behavior for high-risk drugs. This advanced surveillance tool detects changes earlier than traditional methods, aiding in drug safety and risk management.
Area of Science:
- Pharmacovigilance
- Health Services Research
- Biostatistics
Background:
- Post-marketing surveillance of high-risk medications is crucial for identifying safety issues.
- Current surveillance methods using real-world data are underdeveloped.
- Administrative claims data offers a valuable resource for monitoring prescribing patterns.
Purpose of the Study:
- To evaluate a modified statistical process control (SPC) method for post-marketing surveillance of risk minimization measures.
- To assess the method's ability to detect changes in population-level prescribing behaviors using administrative claims data.
- To compare the modified SPC method with a classical SPC approach for drug safety surveillance.
Main Methods:
- Utilized Colorado All-Payers Claims Database (2012-2019) for tapentadol extended release (ER) prescriptions.
- Developed a modified SPC method monitoring model misspecification, establishing a baseline from 2012 data.
- Compared modified SPC with classical SPC, controlling false alarm rates, and aligned detections with policy actions.
Main Results:
- The modified SPC method detected two periods of unusual prescribing behavior (March 2015, April 2016).
- The classical SPC method detected only one period (October 2016), six months after the second modified SPC detection.
- Modified SPC detections better aligned temporally with risk minimization activities.
Conclusions:
- The modified SPC method offers improved detection of prescribing behavior changes compared to classical SPC.
- This tool can assist regulatory agencies in independently monitoring emerging drug risks and prescribing trends.
- The method complements Risk Evaluation and Mitigation Strategies (REMS) assessments by providing timely insights.
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